Medium and long term efficacy of PI-based 2nd line antiretroviral (ARV) therapy in Cambodia is poorly documented when the numbers of patients on treatment and their duration are increasing. For patients in treatment failure , there is no alternative ARV regimen available to date.

This operational research aims to evaluate the Cambodian National Program PI-based 2nd line antiretroviral regimen to assess the proportion of treatment failure and drug resistance ;identify the structural and individual factors associated with treatment failure ; design alternative salvage ARV regimens.

HIV drug resistance is defined by the presence of resistance associated mutations inducing resistance according to the ANRS algorithm to one or more drugs in the standard second line regimen(s) used in Cambodia.

Individual factors will be collected at enrolment by a standardized questionnaire administered during a face to face 20 minutes interview by a trained member of the healthcare team. The questionnaire investigate adherence, perception of side effect, socio-economic status, disclosure and discrimination issues.

Structural risk factors will be collected at the beginning of the study in each participating site through a standardized questionnaire including information on episodes of ARV stock-outs, task-shifting of HIV-care from physician to nurses, availability of psychosocial support, health service provider/patient ratio and health care provider availabilities, quality control, site activities indicators. The questionaire will be filled by the site project coordinator together with the coordinating project social science team.

Biospecimen Retention: Samples With DNA

Plasma HIV RNA and cDNA

Estimated Enrollment:

1500

Study Start Date:

February 2013

Estimated Study Completion Date:

August 2014

Estimated Primary Completion Date:

May 2014 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

All HIV-1 infected adults receiving a PI-based 2nd line regimen in one of the 13 participating national program ARV treatment sites.

Criteria

Inclusion Criteria:

HIV infection

age above 18 years

current PI based 2nd line ARV treatment since at least 6 months

willing to participate and consent signature

Exclusion Criteria:

ongoing PI based 2nd line regimen for less that 6 months at time of study intake

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01801618